Preventing and lessening exacerbations of asthma in school-age children associated with a new term (PLEASANT): study protocol for a cluster randomised control trial
1 Clinical Trials Research Unit, University of Sheffield, School of Health and Related Research, 30 Regent Street, Sheffield S1 4DA, UK
2 Medical Statistics Group, University of Sheffield, School of Health and Related Research, 30 Regent Street, Sheffield S1 4DA, UK
3 Design, Trials and Statistics, University of Sheffield, School of Health and Related Research, 30 Regent Street, Sheffield S1 4DA, UK
4 Health Economics and Decision Science, University of Sheffield, School of Health and Related Research, 30 Regent Street, Sheffield S1 4DA, UK
5 Department of Paediatric Respiratory Medicine, Sheffield Children’s Hospital, Western Bank, Sheffield S10 2TH, UK
6 Department of Psychology, University of Sheffield, Western Bank, Sheffield S10 2TP, UK
7 Academic Unit of Primary Medical Care, University of Sheffield, Samuel Fox House, Northern General Hospital, Herries Road, Sheffield S5 7AU, UK
8 Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, 5th Floor, 151 Buckingham Palace Road, Victoria, London SW1W 9SZ, UK
Trials 2013, 14:297 doi:10.1186/1745-6215-14-297Published: 16 September 2013
Within the UK, during September, there is a pronounced increase in the number of unscheduled medical contacts by school-aged children (4–16 years) with asthma. It is thought that that this might be caused by the return back to school after the summer holidays, suddenly mixing with other children again and picking up viruses which could affect their asthma. There is also a drop in the number of prescriptions administered in August. It is possible therefore that children might not be taking their medication as they should during the summer contributing to them becoming ill when they return to school.
It is hoped that a simple intervention from the GP to parents of children with asthma at the start of the summer holiday period, highlighting the importance of maintaining asthma medication can help prevent increased asthma exacerbation, and unscheduled NHS appointments, following return to school in September.
PLEASANT is a cluster randomised trial. A total of 140 General Practices (GPs) will be recruited into the trial; 70 GPs randomised to the intervention and 70 control practices of “usual care”. An average practice is expected to have approximately 100 children (aged 4–16 with a diagnosis of asthma) hence observational data will be collected on around 14000 children over a 24-month period. The Clinical Practice Research Datalink will collect all data required for the study which includes diagnostic, prescription and referral data.
The trial will assess whether the intervention can reduce exacerbation of asthma and unscheduled medical contacts in school-aged children associated with the return to school after the summer holidays. It has the potential to benefit the health and quality of life of children with asthma while also improving the effectiveness of NHS services by reducing NHS use in one of the busiest months of the year.
An exploratory health economic analysis will gauge any cost saving associated with the intervention and subsequent impacts on quality of life. If results for the intervention are positive it is hoped that this could be adopted as part of routine care management of childhood asthma in general practice.
UKCRN ID: 13572